Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-28 @ 1:59 AM
Study NCT ID:
NCT04343066
Status:
UNKNOWN
Last Update Posted:
2020-10-23
First Post:
2020-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of alveolar ridge thickness at 4 months', 'timeFrame': 'During procedure and at 4 months', 'description': 'Peroperative surgical measurements of the alveolar ridge width at implant sites'}, {'measure': 'Change from baseline of radiographic bone level on CBCT at 1 year post-op', 'timeFrame': 'During procedure and at 1 year', 'description': 'CBCT for buccal bone thickness measurements of the bone crest width at the implant site.'}, {'measure': 'Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray', 'timeFrame': 'During procedure, at 4 months, at 6 months and 1 year', 'description': 'Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact'}, {'measure': 'Change from baseline of bone plate thickness at 4 months', 'timeFrame': 'During procedure and at 4 months', 'description': 'Peroperative buccal and lingual residual bone thickness following implant insertion'}], 'secondaryOutcomes': [{'measure': 'Insertion torque', 'timeFrame': 'During procedure', 'description': 'Manual torque insertion are registered at implant placement.'}, {'measure': 'Change of Clinical parameters from baseline to 1 year post-op', 'timeFrame': 'During procedure, at 6 months and at 1 year', 'description': 'FMBS, FMPS,'}, {'measure': 'Change of FMBS parameters from baseline to 1 year post-op', 'timeFrame': 'During procedure, at 6 months and at 1 year', 'description': 'Change in full mouth bleeding score'}, {'measure': 'Change of Keratinized tissue height from Baseline to 4 months', 'timeFrame': 'During procedure and at 4 months', 'description': 'Measured using a 1.0-mm marked periodontal probe'}, {'measure': 'Histological analysis', 'timeFrame': 'During procedure', 'description': 'Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality'}, {'measure': 'Change of FMPS parameters from baseline to 1 year post-op', 'timeFrame': 'During procedure, at 6 months and at 1 year', 'description': 'Change in full mouth plaque score'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Alveolar ridge augmentation', 'Dental implants', 'Marginal bone remodeling'], 'conditions': ['Dental Implantation', 'Bone Remodeling']}, 'referencesModule': {'references': [{'pmid': '29401469', 'type': 'BACKGROUND', 'citation': 'Shi JY, Jie-Ni, Zhuang LF, Zhang XM, Fan LF, Lai HC. Peri-implant conditions and marginal bone loss around cemented and screw-retained single implant crowns in posterior regions: A retrospective cohort study with up to 4 years follow-up. PLoS One. 2018 Feb 5;13(2):e0191717. doi: 10.1371/journal.pone.0191717. eCollection 2018.'}, {'pmid': '24894890', 'type': 'BACKGROUND', 'citation': 'Liu J, Kerns DG. Mechanisms of guided bone regeneration: a review. Open Dent J. 2014 May 16;8:56-65. doi: 10.2174/1874210601408010056. eCollection 2014.'}, {'pmid': '27224562', 'type': 'BACKGROUND', 'citation': 'Koller CD, Pereira-Cenci T, Boscato N. Parameters Associated with Marginal Bone Loss around Implant after Prosthetic Loading. Braz Dent J. 2016 May-Jun;27(3):292-7. doi: 10.1590/0103-6440201600874.'}, {'pmid': '9590940', 'type': 'BACKGROUND', 'citation': 'Wennerberg A, Hallgren C, Johansson C, Danelli S. A histomorphometric evaluation of screw-shaped implants each prepared with two surface roughnesses. Clin Oral Implants Res. 1998 Feb;9(1):11-9. doi: 10.1034/j.1600-0501.1998.090102.x.'}, {'pmid': '23138742', 'type': 'BACKGROUND', 'citation': 'Rosa MB, Albrektsson T, Francischone CE, Schwartz Filho HO, Wennerberg A. The influence of surface treatment on the implant roughness pattern. J Appl Oral Sci. 2012 Sep-Oct;20(5):550-5. doi: 10.1590/s1678-77572012000500010.'}, {'pmid': '25048469', 'type': 'BACKGROUND', 'citation': 'Esposito M, Ardebili Y, Worthington HV. Interventions for replacing missing teeth: different types of dental implants. Cochrane Database Syst Rev. 2014 Jul 22;(7):CD003815. doi: 10.1002/14651858.CD003815.pub4.'}, {'pmid': '29569767', 'type': 'BACKGROUND', 'citation': 'Donati M, Ekestubbe A, Lindhe J, Wennstrom JL. Marginal bone loss at implants with different surface characteristics - A 20-year follow-up of a randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):480-487. doi: 10.1111/clr.13145. Epub 2018 Mar 23.'}, {'pmid': '11324207', 'type': 'BACKGROUND', 'citation': 'Testori T, Wiseman L, Woolfe S, Porter SS. A prospective multicenter clinical study of the Osseotite implant: four-year interim report. Int J Oral Maxillofac Implants. 2001 Mar-Apr;16(2):193-200.'}, {'pmid': '20367092', 'type': 'BACKGROUND', 'citation': 'Zetterqvist L, Feldman S, Rotter B, Vincenzi G, Wennstrom JL, Chierico A, Stach RM, Kenealy JN. A prospective, multicenter, randomized-controlled 5-year study of hybrid and fully etched implants for the incidence of peri-implantitis. J Periodontol. 2010 Apr;81(4):493-501. doi: 10.1902/jop.2009.090492.'}, {'pmid': '9558555', 'type': 'BACKGROUND', 'citation': 'Nevins M, Mellonig JT, Clem DS 3rd, Reiser GM, Buser DA. Implants in regenerated bone: long-term survival. Int J Periodontics Restorative Dent. 1998 Feb;18(1):34-45.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.', 'detailedDescription': 'This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest.\n\nPatients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4.\n\nA total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method.\n\nThe implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement.\n\nThe patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age: between 20 and 65\n* No systematic contraindication for implant surgery\n* No more than 10 cigarettes/day\n* Previous horizontal bone augmentation 6 months prior to implant placement\n* Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) \\<20% and Full mouth plaque score (FMPS) \\< 20%)\n\nExclusion Criteria:\n\n* Smokers more than 10 cigarettes/day\n* Pregnant/lactating women\n* Alcoholics/drug addicts\n* Uncontrolled diabetics, immunocompromised, blood hemostasis problems\n* Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing\n* Patients not willing to sign the consent form\n* History of radiotherapy in the head and neck region in the last 5 years\n* Active periodontitis on the remaining teeth'}, 'identificationModule': {'nctId': 'NCT04343066', 'briefTitle': 'Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone', 'organization': {'class': 'OTHER', 'fullName': 'Saint-Joseph University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'FMD195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External hex implant', 'description': 'External hexagone implant connection', 'interventionNames': ['Device: Implant insertion']}, {'type': 'EXPERIMENTAL', 'label': 'Internal hex implant', 'description': 'Internal implant connection', 'interventionNames': ['Device: Implant insertion']}], 'interventions': [{'name': 'Implant insertion', 'type': 'DEVICE', 'otherNames': ['Radiological bone level'], 'description': 'In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites.\n\nA final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement.\n\nRandom allocation of implant type per site will be done by the sealed envelope method.\n\nFollow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process.\n\nExam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking \\< 10 cigarettes, previous horizontal bone augmentation, FMBS \\<20% and FMPS \\< 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.', 'armGroupLabels': ['External hex implant', 'Internal hex implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1104 2020', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Saint-Joseph University', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Nada Naaman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Joseph University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': '1 year from date of publication', 'ipdSharing': 'YES', 'description': 'The outcome measurements and patients characteristics might be shared', 'accessCriteria': 'Following a direct request, for meta-analysis or literature review report.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint-Joseph University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Nada BOU ABBOUD NAAMAN', 'investigatorAffiliation': 'Saint-Joseph University'}}}}